Events

Rappel de Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00485-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-09
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00485-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Stryker has become aware that certain lots of the above excelsior sl-10/excelsior 1018 microcatheters have incorrect product expiry dates printed on the packaging. the earliest expiration date of the affected products is may 2016. in the event these products remain in the market after the labelled expiry date, there is a potential hazard that patients exposed to this product may experience severe health consequences.
  • Action
    Stryker is requesting their customers to quarantine any affected lots on hand. Any affected items will be removed by the Stryker Representative and customers will be provided with unaffected replacement stock. This action has been closed-out on 18/08/2016.

Device

Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters
  • Modèle / numéro de série
    Stryker Neurovascular Excelsior SL-10/Excelsior 1018 MicrocathetersExcelsior SL-10 150CM 2 TIPExcelsior 1018 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 90 150CMExcelsior SL-10 Pre-shaped J 150CMCatalogue Numbers: 168189, 144190, 168190, 168191, 168192Lot Numbers: 17026669, 17013156, 17013021,17026849, 17030892, 17045869, 17045959, 17046094, 17046274, 17046229ARTG Numbers: 177031, 149440, 147430
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA